Filterlex Medical and the EIC Accelerator: Stroke Protection in TAVI

Replacing a heart valve through a catheter, a procedure known as TAVI or TAVR, can dislodge particles that travel to the brain and cause strokes. Filterlex Medical, an Israeli company, developed CAPTIS, a device placed in the aorta during the procedure that, according to its website, deflects, captures and removes these particles to give "full-body embolic protection".

In December 2021 Filterlex announced it had been selected to receive €7 million from the EIC Accelerator for its clinical programme. In 2022 it reported a 20-patient first-in-human study with no device complications and no strokes. Since then its only public news, in a November 2023 release, was the study's publication, and no CAPTIS project from the 2021 award appears in the EU's CORDIS database.

What We Could Find

Filterlex's website still leads with the June 2022 announcement of its first-in-human results, presented at the EuroPCR cardiology congress, and lists no later news. We found no further clinical trial on ClinicalTrials.gov, no regulatory approval and no funding announcement after December 2021. We could not access Israeli company records, so we cannot say whether Filterlex is still operating.

The Technology: A Filter in the Aorta

CAPTIS sits in the aortic arch during a valve procedure. The company describes a "triple action design" that deflects particles away from the arteries to the brain, captures them and removes them, and says it needs no additional access point and does not interfere with the procedure. In the first-in-human study at Rabin and Wolfson medical centres in Israel, it reported "100% technical device performance success", "no device related complications" and no cerebrovascular events.

What the EIC Project Promised, and What the Record Shows

The CAPTIS award was meant to fund "clinical program expansion, regulatory approvals, and commercialization". The study on ClinicalTrials.gov started in November 2020, before the 2021 EIC award, and completed in May 2022. We searched the CORDIS Horizon Europe data and found no project with Filterlex as coordinator, so we cannot tell whether a grant agreement was signed or any EIC money paid.

The 2021 award was not Filterlex's first EIC selection. In the EIC SME Instrument Phase 2 cut-off of 5 June 2019, Filterlex was selected, grant only, for CAPTIS, according to the European Commission's list of selected companies; this is the €2.1 million Horizon 2020 grant the company announced in September 2019. CORDIS records an EU contribution of €2,135,000 towards a €3.05 million project from September 2019 to August 2021, to finish animal safety testing and validate the device in human studies on the way to a CE mark, according to CORDIS. The final report describes the animal testing done for ethics approval of the clinical trials. The first-in-human study, which Filterlex said was funded through the Horizon 2020 grant, finished in May 2022, after the project ended, and no CE mark has been announced.

1. First-in-human safetyDelivered20 patients, completed 2022.
2. Expanded clinical programmeNot shownNo further trial registered.
3. Regulatory approvalNot shownNone announced.
4. A reported EIC projectNot shown2021 award not on CORDIS.

What Has Happened Since the Award

The Money

Filterlex closed a $6 million Series A1 in November 2021 and had received a €2.1 million EU Horizon 2020 grant in 2019. Its December 2021 announcement described the EIC money as an equity investment of €7 million. We found no EIC Fund portfolio listing or later funding. In November 2023 Filterlex announced that the 20-patient study had been published in EuroIntervention, with "a 100% success rate in the use of the device", no device-related complications and no cerebrovascular events, and said it "continues to pursue the development and clinical investigation" of CAPTIS.

Why Europe Should Care

Filterlex says particles released during catheter valve procedures can cause harm "from cognitive impairment to debilitating stroke", so a device that stops them would matter to patients. The EU selected Filterlex twice, through Horizon 2020 and the EIC. But after a single small study, the company went quiet, and the EU's records do not show what became of the second award.

The Verdict

Filterlex Medical has not been asked for comment for this article. It is based entirely on company statements, EU data and the trial registry, linked throughout.